CompletedPhase IInterventional

A study to investigate the safety, tolerability, and concentration in the blood of different dose strengths of ENX-102 in healthy volunteers

Researchers are launching a study to understand a new medicine, ENX-102. The main goal is to check how safe it is and how well healthy volunteers tolerate different doses. They also want to see how much of the medicine gets into the blood and how long it stays there after a single dose. This early-stage study, called a Phase I trial, is crucial for finding out if ENX-102 could one day help people with conditions like epilepsy, anxiety, or muscle stiffness. Up to 56 healthy adults, aged 18-55, will take part. Participants will receive either ENX-102 or a dummy pill (placebo) in capsule form. The study involves a screening, a one-week stay with six overnight stays, and a follow-up visit.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Engrail Therapeutics, Inc.

Enrolment target

Start

08 Apr 2021

Estimated completion

20 Oct 2021

Epilepsy, anxiety, spasticity or other CNS disorders

What is this study about?

Researchers are inviting healthy adult volunteers to take part in a study for a new medicine called ENX-102. This is an early-stage study, known as Phase 1, which means it's the first time the medicine is being tested in people. The main aims are to understand how safe ENX-102 is, how well people tolerate it (meaning, how many side effects they experience), and how much of the medicine gets into the bloodstream and how it changes over time with different doses. We want to see if the body handles different amounts of the medicine in different ways.

Even though this study is for healthy volunteers, the information we gather is very important. It will help us decide if ENX-102 could be a promising treatment for serious conditions affecting the brain and nerves, such as epilepsy (which causes seizures), anxiety (which causes feelings of worry and fear), and spasticity (which causes stiff or tight muscles). By understanding the safety and how the medicine acts in the body, we can then plan future studies to see if it actually helps patients with these conditions.

The study is taking place in South Wales and is funded by an American pharmaceutical company. It's designed to be very thorough, with careful monitoring of all participants, to ensure that we collect reliable information in a safe environment.

Key takeaways

It's an early-stage (Phase I) study of a new medicine called ENX-102.
The main goals are to check safety, side effects, and how the medicine acts in the body.
The study involves healthy adults aged 18-55.
Participation includes a week-long stay with 6 overnights, plus screening and follow-up.
You might receive ENX-102 or a dummy pill (placebo).
No direct health benefits are expected, but results may help future treatments for epilepsy, anxiety, or muscle stiffness.

Who may be eligible?

To join this study, you need to be a healthy man or woman between the ages of 18 and 55. Your body weight and height should fall within a healthy range (a Body Mass Index of 18 to 35).

If you are a woman who could become pregnant, you must agree to use two effective methods of contraception (like the pill and a condom, or having no sex) from the day before the study drug is given until three months after your last dose. We'll also do a pregnancy test before you start and during the study. If you are a woman who can’t get pregnant (for example, if you’ve had a hysterectomy or have gone through menopause), you can still take part.

If you are a man, and able to have children, you must also agree to use two effective methods of contraception (including a condom) with any female partner who could become pregnant, or have no sex, from the day before the study drug is given until three months after your last dose. You must also be generally healthy and able to follow all the study instructions.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I a healthy adult between 18 and 55 years old?
Do I have a Body Mass Index (BMI) between 18 and 35?
If I am a woman, can I use two effective birth control methods for 3 months after the study, or am I unable to get pregnant?
If I am a man, can I use two effective birth control methods with my partner for 3 months after the study, if my partner could become pregnant?
Am I willing and able to follow all study instructions and attend all visits?

Answer every question to see your result.

What does participation involve?

If you take part, you'll first have a screening visit within 28 days before the study starts to check if you're eligible. The main part of the study involves one treatment period, which will last up to 7 days and include 6 overnight stays at the clinical unit. Finally, you'll have one follow-up visit 7 days after you leave the unit. In total, the study will involve a screening and up to 8 days of your time over about a month.

During your stay, you'll be part of a group of 8 people. In each group, 6 people will receive ENX-102, and 2 people will receive a dummy pill (placebo) that looks the same but contains no active medicine. Neither you nor the study team will know who is getting what until the study is over. The medicine, or placebo, will be given as capsules. Throughout your time, blood samples will be taken regularly to measure the amount of ENX-102 in your blood. Your heart rate, blood pressure, and heart's electrical activity (ECG) will also be checked often. You may need to have small patches of hair shaved or clipped for the ECG sticky pads.

Potential risks and benefits

This study is not expected to directly improve your health. However, the information gathered could greatly help develop new treatments for conditions like epilepsy, anxiety, and muscle stiffness in the future. As with any medical study, there are some potential risks. Blood samples might cause mild pain or bruising. Blood pressure cuffs can cause temporary discomfort. ECG pads might be uncomfortable to remove, and in rare cases, a small amount of hair may need to be clipped. There's also a small risk of COVID-19 exposure, but the clinic takes precautions like health checks, masks, and tests. For male participants, using contraception for 3 months after the study is required to prevent harm to an unborn child. Pregnant or breastfeeding women cannot take part, and women of childbearing potential will also need to use contraception for 3 months. Your health will be closely monitored, and you are free to withdraw from the study at any time.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Simbec Research Limited
City only
Mid Glamorgan, United Kingdom

Common questions

What is ENX-102?

ENX-102 is a new investigational medicine being tested for the first time in people to see if it’s safe and how it works in the body.

Will I definitely get the actual medicine?

No, in each group, 6 out of 8 people get ENX-102, and 2 get a dummy pill (placebo). You won't know which you received until after the study.

Why do you need healthy volunteers?

Testing in healthy volunteers first helps us understand the basic safety and how the medicine behaves in the body before giving it to people who are unwell.

Where does the study take place?

The study will be carried out at a special clinical research unit called Simbec-Orion in South Wales.

Will I get paid to take part?

The study information doesn't mention payment, but it's a good question to ask the study team if you are thinking of participating.

How to find out more

Eve Taylor

Eve.Taylor@engrail.com +1 858 342 5478 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.